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Regulatory Science

Heat-not-burn (HNB) products, which heat a mixture of tobacco and other compounds to temperatures below those at which combustion occurs, deliver an inhalable aerosol containing nicotine and other chemicals. Although previous attempts by the tobacco industry to introduce such products have been largely unsuccessful, Philip Morris International’s iQOS is successfully being test marketed in several countries. In addition, Philip Morris Products S.A. has submitted modified risk tobacco product applications to the FDA to permit marketing iQOS in the United States.

The Administration Core will have primary responsibility for overall scientific and financial management of the TCORS. The integrated health effects, behavior, and impact analysis will provide actionable information for regulation of and public communications about current and emerging tobacco products. The TCORS’ five projects will be complemented by four cores (including this one), which include Rapid Response Projects and career enhancement activities. The Administration Core will meet its responsibility by implementing five specific aims:

The Career Enhancement Core will continue and expand our current efforts to build the community of investigators with the knowledge, skills and experience to conduct high-quality cutting-edge tobacco regulatory science.

Cigarette smoking among U.S. adolescents has declined, but similar declines have not occurred in youth smokeless tobacco (ST) use. There is also a growing trend among adolescents and young adults of poly-use of multiple tobacco products in combination. In recent decades, ST use has shifted from an older to a younger demographic, coincident with increasing industry marketing and expanding diversity in ST product characteristics. These new ST products include different types, brands, flavors, and varying levels of bioavailable nicotine and cancer-causing nitrosamines.

Healthcare costs play a central role in FDA regulatory impact analysis. Many factors contribute to tobacco- attributable healthcare costs, including changing tobacco product use patterns, sociodemographic characteristics, health status, and socioeconomic status (SES). The central goal of this project is to develop economic models that analyze the impact of new patterns of tobacco product use on healthcare costs for different populations including those that are particularly vulnerable.

Over the past decade, use of electronic cigarettes (e-cigarettes) has been rapidly growing. Because e-cigarettes are relatively new to the market, there is little biologic data on their health effects, particularly how these health effects are affected by specific product characteristics.

Components and parts of electronic cigarettes (e-cigarettes), such as batteries and e-liquids, are within the Food and Drug Administration’s regulatory authority. There are, however, significant gaps in understanding of how specific aspects of these components and parts influence the overall health effects of e-cigarettes, including short-term cardiovascular effects.